Nasal Outcomes Using Saline Irrigations After Endonasal Pituitary Surgery

Not Applicable

Recruiting

• Conditions: Pituitary Tumor
• Interventions: Other: Nasal saline irrigation

• Registration Number: NCT05659524
• Lead Sponsor: Lori Wood

Brief Summary

This is a prospective, single-blinded, multicenter study evaluating the benefit of sinonasal irrigations following endoscopic pituitary surgery. The goal of this study is to create practice changing guidelines with objective data highlighting the importance of irrigations on postoperative outcomes for pituitary surgery.

Detailed Description

This prospective study, coupled with the results of the recent POET study evaluating the role of antibiotics in postoperative outcomes for pituitary surgery, will guide physicians in the optimal management of patients following endoscopic pituitary surgery.

The investigator group has an established record of completing multicenter studies (e.g., POET, TRANSPHER) that have influenced clinical practice guidelines, raised the profile of Barrow in the pituitary and skull base community, and resulted in numerous peer-reviewed publications and awards.

Study Timeline

• Study Start: 2020-12-18
• Study First Submitted: 2021-11-29
• Study First Submitted QC: 2022-12-19
• Study First Posted: 2022-12-21
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-17
• Last Update Posted: 2024-04-19
• Primary Completion: 2028-12-31
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nasal saline irrigation	Nasal saline irrigation	Patients randomized to standard postoperative nasal care with twice a day saline sinonasal irrigations

Primary Outcome Measures

Name	Time	Method
Difference in mean sinonasal quality of life	12 weeks	Difference in mean sinonasal quality of life between groups as determined by patient reported Sino-nasal Outcome Test (SNOT-22) scores at 4 weeks. SNOT-22 scoring can be completed during a clinic visit or by phone interview. It is critical that the follow-up times are standardized because symptoms improve with time. A reduction in SNOT-22 composite score is indicative of improvement in symptoms.

Secondary Outcome Measures

Name	Time	Method
Sinonasal quality of life as determined by patient-reported Anterior Skull Base Nasal Inventory-12 (ASK Nasal-12) scores	12 weeks	Sinonasal quality of life as determined by patient-reported ASK Nasal-12 scores at; 1week, 2 weeks, 4 weeks, 8 weeks and 12 weeks after surgery.
Sinonasal quality of life as determined by Sinonasal Outcomes Test 22 (SNOT-22)	12 weeks	Sinonasal quality of life as determined by Sinonasal Outcomes Test 22 (SNOT-22) overall scores at 1week, 2 weeks, 4 weeks, 8 weeks, and 12 weeks after surgery.
Endoscopy findings	12 weeks	Postoperative nasal endoscopy findings of purulence, nasal crusting, polyps, and synechiae as estimated on the Endoscopic Appearances scale developed by Lund- Kennedy at 1 week, 4 weeks, and 12 weeks after surgery.
Sinonasal quality of life as determined by SNOT-22 rhinological subscale scores	12 weeks	Sinonasal quality of life as determined by SNOT-22 rhinological subscale scores at 1 week, 2 weeks, 4 weeks, 8 weeks, and 12 weeks after surgery.
Sinonasal quality of life, as determined by Sinonasal Outcomes Test 22 (SNOT-22), of subgroups including septal flap reconstruction and no septal flap reconstruction.	12 weeks	Sinonasal quality of life, as determined by Sinonasal Outcomes Test 22 (SNOT-22), of subgroups including septal flap reconstruction and no septal flap reconstruction.

Trial Locations

Locations (2)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

Barrow Neurological Institute at St. Joseph's Hospital and Medical Center; 🇺🇸 Phoenix, Arizona, United States